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ICH: BIO Comments on ICH E8(R1) General Considerations for Clinical Studies

September 30, 2019

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Clinical Trials: BIO Comments on FDA Draft Guidance Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs.

Pediatrics: BIO Comments on FDA Draft Guidance Postapproval Pregnancy Safety Studies

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments to the Draft Guidance on Postapproval Pregnancy Safety Studies.

Real World Evidence: BIO Submits Comment Letter to FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics.

BIO Releases 5th Annual Emerging Therapeutic Company Trend Report Showing Record Year for Venture Capital Funding

Washington, D.C. (May 31, 2019) – Today, the Biotechnology Innovation Organization (BIO) released the 2019 Emerging Therapeutic Company Trend Report, highlighting ten years (2009-2018) of biotechnology funding and deal making across five areas: venture capital, Initial Public Offerings (IPOs), follow-on public offerings, licensing, and acquisitions. The report also contains a 2019 snapshot of the industry’s clinical pipeline to highlight the significant contribution of emerging companies.

Rare Diseases: BIO Comments on FDA Draft Guidance Rare Diseases: Natural History Studies for Drug Development

BIO appreciates the Agency’s work to develop a much-needed guidance on natural history studies for rare disease drug development. The Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to natural history studies for rare disease drug development. Such guidance ensures that Sponsors have appropriate information for developing new therapies for rare disease patients, especially given that many rare diseases still do not have an FDA approved treatment. In the following pages of this letter, BIO has included general comments as well as line edits that we believe will make the Draft Guidance more useful for various stakeholders.

PFDD: BIO Comments on FDA Draft Guidance Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019

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Biomarkers: BIO Submits Comments on FDA Draft Guidance Biomarker Qualification: Evidentiary Framework

February 11, 2019

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RWE: BIO Submits Comments on FDA Framework for a Real-World Evidence Program

February 5, 2019

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BIO Comments on FDA Draft Guidance Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

December 17, 2019

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